Evaluation of combinations of bedaquiline, moxifloxacin,...

In the News

Vacancy: Research Scientist (2 posts)

IHI is looking for experienced Research Scientists to work with a project bearing the title: Broad One Health Endectocide-based Malaria Intervention in Africa (BOHEMIA) funded by the UNITAID. This project …

It’s World Malaria Day today: We’re for “Zero malaria”

We’re for “Zero malaria” (Dar es Salaam, April 25 2019) It’s World Malaria Day today. IHI joins with the Ministry of Health, Community Development, Gender, Elderly and Children through the …

Recent Projects

Calcium supplementation on pregnant women

Project summary This is a trial-based study funded by the Bill and Melinda Gates Foundation. It intends to generate evidence for decision-making on the potential non-inferiority of a lower dose …

Sustainable, Healthy, Learning Cities and Neighbourhoods

The Sustainable, Healthy, Learning Cities and Neighbourhoods is an exciting project in which IHI works with a consortium of partners from Asia and Africa to 1) develop capacity for improved …

A phase 2 Open‐Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of combinations of bedaquiline, moxifloxacin, PA‐824 and pyrazinamide during 8 weeks of treatment in Adult Subjects with Newly Diagnosed Drug‐Sensitive or Multi Drug‐ Resistant, Smear‐Positive Pulmonary Tuberculosis.

NC005 is a multicenter phase 2 Open‐Label Partially Randomized Trial to evaluate the efficacy, safety and tolerability of combinations of bedaquiline, moxifloxacin, PA‐824 and pyrazinamide during 8 weeks of treatment in Adult Subjects with Newly Diagnosed Drug‐Sensitive or Multi Drug‐ Resistant, Smear‐Positive Pulmonary Tuberculosis. The primary objective of the study is to assess the mycobactericidal activity of combinations of bedaquiline, moxifloxacin, PA‐824 and pyrazinamide regimens during 8 weeks of treatment. IHI enrolled only drug sensitive TB participants, whereby 31 participants were enrolled. Participants were randomized to receive either bedaquilline 400mg (J) (loading dose/t.i.w.), Pa824 200mg (Pa) and Pyrazinamide 1500mg (Z); or J (200mg)PaZ; or HRZE. The HRZE treatment arm is included as a control for the drug‐sensitive treatments. Enrollment and follow up complemented in February 2016 and currently participants are on a six monthly telephonic survival follow up until early 2018.

Lead Scientists:

Frederick Haraka

Francis Mhimbira

Partners

Mbeya Medical Research Centre-NIMR
TB Alliance
Swiss Tropical and Public Health Insitute

Funders

Global Alliance for TB drug development (TB Alliance)

Projects Location

A PIXELBASE DESIGN
© Ifakara Health Institute (IHI), 2016